Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-09 @ 7:17 AM
Study NCT ID:
NCT02053818
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-11', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-02-01', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Haemodynamic effects of opioids', 'timeFrame': 'From induction anaesthesia until cardiopulmonary bypass', 'description': 'Evaluation of haemodynamic indexes (cardiac index, stroke volume index, central venous oxygenation, blood pressure, Heart rate) together with echocardiographic evaluation of systolic and diastolic function.\n\nEvaluation both by single opioid and combination with propofol'}, {'measure': 'Cardioprotection', 'timeFrame': '0,4,9,15 and 40 hours after surgery', 'description': 'Evaluation based on myocardial biochemical markers CK-MB, Troponin-T and Nt-Pro-BNP preoperative and 4, 9 and 15 and 40 hours after surgery'}], 'primaryOutcomes': [{'measure': 'Cognitive function score', 'timeFrame': 'Postoperative day 4', 'description': 'Cognitive function evaluated by Palo Alto Veterans Hospital Test on all patients'}, {'measure': 'Fast-track potential', 'timeFrame': 'Time ((mean hours) to eligible discharge from ICU (up to 48 hours)', 'description': 'Ventilation time and eligible time to discharge based on ICU score'}], 'secondaryOutcomes': [{'measure': 'Eligible time to discharge from ICU', 'timeFrame': 'Time (hours) to ICD4', 'description': 'Estimation on hours in ICU before the patients were eligible for discharge from ICU = ICD4 (Total score \\< 5, and no single score \\> 2) using an objective ICU score. The ICU score is done each hour after extubation'}, {'measure': 'Postoperative cognitive dysfunction', 'timeFrame': 'Postoperative day 1 and 30', 'description': 'Changes from pre-operative cognitive function to postoperative cognitive function on day 1, 4 and 30 using cognitive function test from Palo Alto Veterans Hospital Test on all patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive dysfunction', 'Cardioprotection', 'Recovery', 'Renal function', 'ICU discharge'], 'conditions': ['Ischaemic Heart Disease', 'Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.', 'detailedDescription': '1. Haemodynamic effects, evaluated by invasive haemodynamic data (arterial line and PAC) of opioid given as single drug and in combination with Propofol (first 30 patients only).\n2. Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30\n3. Recovery quality and time parameters using objective ICU score criteria\n4. Cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR)\n\nExclusion Criteria:\n\n* Ejection Fraction \\< 30%\n* Previous Myocardial Infarction within 4 weeks\n* Severe pulmonary hypertension (mean pulmonary artery pressure (mPAP) \\> 33% of mean arterial pressure (MAP)\n* Arterial hypertension (Sap \\> 180, Dap \\> 110)\n* Diabetes, Non- and Insulin dependent\n* Non usable echocardiography windows'}, 'identificationModule': {'nctId': 'NCT02053818', 'acronym': 'PRECON2', 'briefTitle': 'Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Fast-track in Cardiac Surgery. Remifentanyl & Sufentanil Anaesthesia for CABG+/-AVR Evaluated by Recovery, Cognitive Dysfunction, Haemodynamics (PAC/TTE) and Cardiac Biochemical Markers (CKMB, TNT, Pro-BNP)', 'orgStudyIdInfo': {'id': '2010-022428-58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil', 'description': 'Remifentanil the basic opioid drug in anesthesia', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sufentanil', 'description': 'Sufentanil the basic opioid drug in anesthesia', 'interventionNames': ['Drug: Sufentanil']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia', 'armGroupLabels': ['Remifentanil']}, {'name': 'Sufentanil', 'type': 'DRUG', 'otherNames': ['Sufenta'], 'description': 'Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia', 'armGroupLabels': ['Sufentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'overallOfficials': [{'name': 'Carl-Johan Jakobsen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Consultant, Ass professor', 'investigatorFullName': 'Carl-Johan Jakobsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}